The Recall Desk
SevereFDA (Drugs)·D-0314-2022·Announced 2022-01-05

SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug with a sterility defect. Lack of sterility assurance in intravenous medications poses a significant risk of serious infection and harm to patients, meeting the rubric criterion for Severe (Class II with risk of significant injury).

Plain-English summary

SterRx, LLC is recalling Norepinephrine in 5% Dextrose Injection, 8 mg per 250 mL (32 mg/mL), NDC 70324-476-01, lot code S21409/CCR. The recall affects 1,428 bags distributed nationwide in the United States.

The recall was initiated due to lack of assurance of sterility. This product is a prescription-only injectable medication used in hospital and clinical settings.

Patients and healthcare providers who have received or are currently using this product should contact their healthcare provider or pharmacy for guidance. The FDA classifies this as a Class II recall.

The recalled product

Product
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Cardiovascular Agent
Hazard
  • sterility-defect
  • injection-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • S21409/CCR

Distribution

Distributed nationwide across the United States.

Related recalls

Same category